NIH.GOV: Antidepressants and Violence-Problems at the Interface of Medicine & Law [View all]

"Recent regulatory warnings about adverse behavioural effects of antidepressants in susceptible individuals have raised the profile of these issues with clinicians, patients, and the public. We review available clinical trial data on paroxetine and sertraline and pharmacovigilance studies of paroxetine and fluoxetine, and outline a series of medico-legal cases involving antidepressants and violence.

Both clinical trial and pharmacovigilance data point to possible links between these drugs and violent behaviours. The legal cases outlined returned a variety of verdicts that may in part have stemmed from different judicial processes. Many jurisdictions appear not to have considered the possibility that a prescription drug may induce violence.

...Legal systems are likely to continue to be faced with cases of violence associated with the use of psychotropic drugs, and it may fall to the courts to demand access to currently unavailable data. The problem is international and calls for an international response.

...In 1989, Joseph Wesbecker shot dead eight people and injured 12 others before killing himself at his place of work in Kentucky. Wesbecker had been taking the selective serotonin reuptake inhibitor (SSRI) antidepressant fluoxetine for four weeks before these homicides, and this led to a legal action against the makers of fluoxetine, Eli Lilly . The case was tried and settled in 1994, and as part of the settlement a number of pharmaceutical company documents about drug-induced activation were released into the public domain. Subsequent legal cases, some of which are outlined below, have further raised the possibility of a link between antidepressant use and violence.

...Some regulators, such as the Canadian regulators, have also referred to risks of treatment-induced activation leading to both self-harm and harm to others . The United States labels for all antidepressants as of August 2004 note that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric” . Despite these developments, few data are available on the links between antidepressant usage and violence. We here offer new data, review the implications of these data, and summarise a series of medico-legal cases.

...In these trials, hostile events are found to excess in both adults and children on paroxetine compared with placebo, and are found across indications, and both on therapy and during withdrawal. The rates were highest in children with obsessive-compulsive disorder (OCD), where the odds ratio of a hostile event was 17 times greater (95% confidence interval

Emotional blunting

Another mechanism that may contribute to hostile events is treatment-induced emotional blunting. Several reports published since 1990 have linked SSRI intake with the production of emotional blunting, detachment, or an amotivational syndrome, described in one report as the equivalent to a

“chemical lobotomy”

. It is quite common in clinical practice to find people who say they simply are not bothered any more. Things that would previously have worried them no longer do so...

Mania and psychosis

Another mechanism that may link SSRIs to violence are the manic or psychotic states reported to be induced by drug treatment. These drug-induced states often resolve once the medication is removed. However, the full dimensions of treatment-induced psychotic or manic reactions have yet to be mapped; some may continue for a long period after treatment has stopped . It has recently been estimated that these drug-induced manic or psychotic states may account for up to eight percent of admissions to psychiatric facilities .

...The development of a psychotic episode or of command hallucinations has traditionally been linked to both violence and suicide. The labels for most SSRIs now concede a causal relationship to psychosis and to hallucinations...(more)

Conclusion

The new issues highlighted by these cases need urgent examination jointly by jurists and psychiatrists in all countries where antidepressants are widely used. The problem is international, and it would make sense to organise an international effort now.

Annex: The Illustrative Medico-Legal Cases

Case 1

DS was a 60-year-old man with a history of five prior anxiety/depressive episodes. These did not involve suicidality, aggressive behaviour, or other serious disturbance. All prior episodes had resolved within several weeks...

...In 1998, a new family doctor, unaware of this adverse reaction to fluoxetine, prescribed paroxetine 20 mg to DS, for what was diagnosed as an anxiety disorder. Two days later having had, it is believed, two doses of medication, DS using a gun put three bullets each through the heads of his wife, his daughter who was visiting, and his nine-month-old granddaughter before killing himself.

Case 3

DH was a 74-year-old man from New South Wales with a history of mixed anxiety/depressive episodes, many of which resolved without drug treatment. He had no history of violence or suicidality, and had remained gainfully employed throughout...

That night, apparently feeling worse after a first dose of sertraline, DH took four more doses of sertraline. The next morning, after his wife got up he met her in the kitchen and strangled her...(more)

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

This website is a collection of 4,800+ news stories with the full media article available, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals) or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned.